Dr. Reddy serves as a Toxicology Advisor for Kovina Therapeutics. He is an experienced drug development professional with over thirty years of experience in global pharmaceutical drug discovery and development with Sanofi and then Eli Lilly & Company. Dr. Reddy led nonclinical safety and regulatory assessments on several early and late-stage cross-functional oncology and endocrine/neuro programs. In addition, Dr. Reddy provided scientific consultation and expertise, including design of clinical development plans, and interpretation of regulatory guidance. He was a critical contributor in delivering nonclinical toxicology packages to support first in human studies (INDs) for many drug candidates and successfully submitted two NDAs (Evista, Alimta) and two BLAs(Cyramza and Lartruvo). During his tenure at Lilly, he developed a strong regulatory and drug development expertise, interacted with worldwide regulatory agencies, and addressed safety issues for drugs during pre-IND, end of Phase II, pre-NDA, pre BLA, NDA, BLA, FDA, EU and PMDA (Japan) meetings. In addition, Dr. Reddy worked as an ICH S9 Expert Working Group (EWG) member and played an active role as a US Pharma representative in drafting ICH S9 guidance document for developing anticancer pharmaceuticals.
Dr. Reddy received his PhD., from Utah State University, MS from the University of Mississippi Medical Center and DVM (BVSc) from A.P. Agricultural University, India. He completed his post-doctoral fellowship at the University of Nebraska Medical Center. Dr. Reddy has numerous publications and organized and chaired symposium and continuing education courses at national and international meetings and NCI/FDA workshops.